| Eligibility |
Inclusion Criteria:
Inclusion criteria that apply to potential Donor participants:
1. Capable of reading and writing English and voluntarily provide written informed
consent to participate in the study and comply with all study procedures.
2. Generally healthy, pre-menopausal women age 18-45 years old.
3. Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use
of long-acting progestin or continuous use of oral contraceptives.
4. Free of vaginal symptoms, such as odor, discharge, or itching.
5. Willing to be asked questions about personal medical, sexual, and behavioral history.
6. Willing to self-collect cervicovaginal secretions and vaginal swab samples.
7. Agree to abstain from using insertive vaginal feminine products (i.e. Tampons,
menstrual cups, sex toys), other vaginal products (cleansing products, spermicides,
lubricants, hygiene powders and sprays), vaginal and anal intercourse, taking baths,
going swimming, sitting in hot tub, or wearing thong underwear during the entire
sample donation period (from screening to the final donation). Sanitary napkins are
acceptable.
Inclusion criteria that apply to potential Recipient participants:
1. Capable of reading and writing English and voluntarily provide written informed
consent to participate in the study and comply with all study procedures.
2. Generally healthy, pre-menopausal women age 18-45 years old.
3. Experiences recurrent bacterial vaginosis (BV) (at least 3 diagnoses in their
lifetime), and has received treatment for BV on at least 1 prior occasion in the past
5 years.
4. Currently needing treatment for vaginal symptoms clinically diagnosed as BV (>= 3
Amsel criteria and confirmed in the laboratory by Nugent score >= 4) and suitable for
0.75% metronidazole vaginal antibiotic treatment.
5. Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use
of long-acting progestin or continuous use of oral contraceptives.
6. Women who are not sterilized or who are not using an Intra-uterine Device (IUD) or
form of hormonal contraception must agree to barrier contraception (i.e. Condoms,
diaphragm) for heterosexual intercourse during the study. Counseling will be provided
for use of barrier contraception without the use of adjunctive spermicide or
lubricant.
7. Willing to be asked questions about personal medical, sexual, and behavioral history.
8. Willing to self-collect cervicovaginal secretions and vaginal swab samples.
9. Willing to undergo VMT procedure.
10. Agree to abstain from vaginal intercourse, unless using a condom, for at least the 28
days after the VMT procedure. Condoms will be provided.
11. Agree to avoid taking baths, swimming, sitting in a hot tub, or wearing thong
underwear for at least the 28 days after the VMT procedure.
12. Agree to abstain from using insertive vaginal feminine products (i.e. Tampons,
menstrual cups, sex toys), vaginal cleansing products, spermicides, lubricants, or
other vaginal products not approved by the study investigators after the VMT procedure
through visit 8 (~6 months). Sanitary napkins are acceptable.
Exclusion Criteria:
Exclusion criteria that apply to potential Donor participants:
1. Any history of bacterial vaginosis, recurrent yeast infection, trichomoniasis,
syphilis, human papilloma virus (HPV) including genital warts, high grade pap smear,
herpes, pelvic inflammatory disease, recurrent urinary tract infection, mycoplasma.
2. Testing positive for HIV, Hepatitis A/B/C, syphilis, Human T-lymphotrophic Virus
(HTLV)-I/II, WNV, Epstein-Barr Virus (EBV), rubella, toxoplasma gondii, Herpes Simplex
Virus (HSV)-1/2, yeast or bacteria that are considered pathogenic/abnormal and/or show
antibiotic resistance, chlamydia, gonorrhea, mycoplasma genitalium, trichomonas
vaginalis, HPV.
3. Cervicovaginal secretions (CVS) not dominated by one of the common vaginal
lactobacillus species, as determined by qPCR.
4. Currently pregnant or breastfeeding.
5. History of gonorrhea or chlamydia within 12 months prior to screening.
6. Travel or sexual partner travel to regions or countries where Ebola or Zika outbreaks
occurred in the past 12 months.
7. Any other medical, travel, or behavioral history that deems donors of human cells,
tissues, and cellular and tissue-based products (HCT/Ps) ineligible.
8. HIV/AIDS or other immunodeficiency, or testing out of the range of normal clinical
parameters for general measures of immunocompetence.
9. Hysterectomy.
10. Use of vaginal ring (e.g., NuvaRing) within 3 days of screening or during the course
of the study.
11. Investigational drug use within 30 days or 10 half-lives of the drug, whichever is
longer, of enrollment visit, or planned participation in an investigational drug study
while participating in this study.
12. IUD insertion or removal, cervical cryotherapy, or cervical laser treatment within 2
months prior to screening.
13. Any condition requiring regular periodic use of systemic antibiotics during the study.
14. New use of long-acting hormonal treatments. Participant may be enrolled if stable (>3
months) or existing therapy as determined by the investigator.
15. Any social, medical, or psychiatric condition, including history of drug or alcohol
abuse that in the opinion of the investigator would make it unlikely for the
participant to comply with the study or would complicate interpretation of data from
her participation.
16. Menopause defined as more than 12 consecutive months of amenorrhea without another
known cause.
17. Irregular menstrual cycles that preclude scheduling appointments to avoid
menstruation.
18. Donors will be screened for cytomegalovirus (CMV), Rubella, and Varicella Zoster Virus
(VZV) IgG, which will not be a criterion for exclusion, but samples from CMV positive
and/or Rubella positive and/or VZV positive Donors will only be matched with CMV
positive and/or Rubella and/or VZV positive Recipients.
19. Abnormal finding on exam, which, in the opinion of the investigator, precludes
participation.
20. Sexual history or current sexual behavior, or having sexual partners that engage in
such behaviors, which introduces increased risk of sexually transmitted infections or
exposure to pathogenic organisms.
21. Medication use, recent vaccinations, sources of income, or other behaviors, which in
the opinion of the investigator, precludes participation.
Exclusion Criteria that apply to potential Recipient participants
1. Current pregnancy, within 2 months of pregnancy, planning to become pregnant within
the next 6 months, and/or currently breastfeeding.
2. HIV/AIDS or other immunodeficiency.
3. Testing positive for HIV, HTLV-I/II, yeast infection, chlamydia, gonorrhea, mycoplasma
genitalium, trichomonas, antibiotic-resistant bacteria in culture, or human Chorionic
Gonadotrophin (hCG) (urine).
4. Hysterectomy.
5. High grade pap smear within the past year.
6. Use of vaginal ring (e.g., NuvaRing) during the course of the study.
7. Investigational drug use within 30 days or 10 half-lives of the drug, whichever is
longer, of enrollment visit, or planned participation in an investigational drug study
while participating in this study.
8. IUD insertion or removal, cervical cryotherapy, or cervical laser treatment within 2
months prior to screening.
9. Any condition requiring regular periodic use of systemic antibiotics during the study.
10. New use of long-acting hormonal treatments. Participant may be enrolled if stable (>3
months) or existing therapy as determined by the investigator.
11. Any social, medical, or psychiatric condition, including history of drug or alcohol
abuse that in the opinion of the investigator would make it unlikely for the
participant to comply with the study or would complicate interpretation of data from
her participation.
12. Menopause defined as more than 12 consecutive months of amenorrhea without another
known cause.
13. Recipients will be screened for cytomegalovirus (CMV), Rubella, and Varicella Zoster
Virus (VZV) IgG, which will not be a criterion for exclusion, but samples from CMV
positive and/or Rubella positive and/or VZV positive Donors will only be matched with
CMV positive and/or Rubella and/or VZV positive Recipients.
14. Abnormal finding on exam, which, in the opinion of the investigator, precludes
participation.
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